- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
5.12 Study reports
The sponsor is responsible for ensuring the preparation and appropriate approval(s) of a comprehensive final clinical study report suitable for regulatory purposes, whether or not the trial has been completed. The sponsor must also submit any relevant safety information (including safety) that becomes available during the trial and/or annual reports as required by the relevant health authorities.